A Study of Japanese Rheumatoid Arthritis Participants

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: LY2127399

• Registration Number: NCT01253291
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-03
• Primary Completion: 2013-09
• Study Completion: 2014-03
• Results First Submitted: 2018-03-24
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Results First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
120 mg LY2127399	LY2127399	Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.
30mg/120 mg LY2127399	LY2127399	Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline up to 72 weeks	Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in CD20+ B-cell Count	Baseline and Weeks 12, 24, 36, 52, and 72	CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.
Percent Change From Baseline in Peripheral B-cell Subsets	Baseline and Weeks 12, 24, 36, 52, and 72	Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.
Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody	Baseline and Weeks 12, 24, 36, 52, and 72	Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]	Baseline and Weeks 12, 24, 36, 52, and 72	IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.
Percent Change From Baseline in Rheumatoid Factor (RF)	Baseline and Weeks 12, 24, 36, 52, and 72	RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.
Percent Change From Baseline in C-Reactive Protein (CRP)	Baseline and Weeks 12, 24, 36, 52, and 72	CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Baseline and Weeks 12, 24, 36, 52, and 72	ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇯🇵 Tokyo, Japan